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4. AB1291 COVID-19 AND CRYOGLOBULINEMIC VASCULITIS.LONG-TERM SURVEY STUDY ON THE IMPACT OF PANDEMIC AND VACCINATION ON A LARGE PATIENT’S POPULATION

Author

Gragnani, L., primary, Visentini, M., additional, Lorini, S., additional, Santini, S., additional, Lauletta, G., additional, Mazzaro, C., additional, Urraro, T., additional, Luca, Q., additional, Cacciapaglia, F., additional, Ruscitti, P., additional, Tavoni, A., additional, Marri, S., additional, Cusano, G., additional, Petraccia, L., additional, Naclerio, C., additional, Treppo, E., additional, Del Frate, G., additional, Di Cola, I., additional, Raimondo, V., additional, Scorpiniti, D., additional, Monti, M., additional, Puccetti, L., additional, Elia, G., additional, Fallahi, P., additional, Basili, S., additional, Scarpato, S., additional, Iannone, F., additional, Casato, M., additional, Antonelli, A., additional, Zignego, A. L., additional, and Ferri, C., additional

Published
2023
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5. Profiling the risk of hepatocellular carcinoma after long-term HCV eradication in patients with liver cirrhosis in the PITER cohort

Author

Kondili, L, Quaranta, M, Cavalletto, L, Calvaruso, V, Ferrigno, L, D'Ambrosio, R, Simonelli, I, Brancaccio, G, Raimondo, G, Brunetto, M, Zignego, A, Coppola, C, Iannone, A, Biliotti, E, Verucchi, G, Massari, M, Licata, A, Barbaro, F, Persico, M, Russo, F, Morisco, F, Pompili, M, Vigano, M, Puoti, M, Santantonio, T, Villa, E, Craxi, A, Chemello, L, Panetta, V, Gaeta, G, Filomia, R, Coco, B, Monti, M, Amoruso, D, Madonia, S, Ieluzzi, D, Taliani, G, Badia, L, Migliorino, G, Giorgini, A, Masarone, M, Blanc, P, Cossiga, V, De Siena, M, Tata, X, Rumi, M, Chessa, L, Lampertico, P, Ferrari, C, Gentile, I, Parruti, G, Baiocchi, L, Ciancio, A, Invernizzi, P, Federico, A, Torti, C, Morsica, G, Andreone, P, Aghemo, A, Popoli, P, Vella, S, Kondili L. A., Quaranta M. G., Cavalletto L., Calvaruso V., Ferrigno L., D'Ambrosio R., Simonelli I., Brancaccio G., Raimondo G., Brunetto M. R., Zignego A. L., Coppola C., Iannone A., Biliotti E., Verucchi G., Massari M., Licata A., Barbaro F., Persico M., Russo F. P., Morisco F., Pompili M., Vigano M., Puoti M., Santantonio T., Villa E., Craxi A., Chemello L., Panetta V., Gaeta G. B., Filomia R., Coco B., Monti M., Amoruso D. C., Madonia S., Ieluzzi D., Taliani G., Badia L., Migliorino G. M., Giorgini A., Masarone M., Blanc P., Cossiga V., De Siena M., Tata X., Rumi M. G., Chessa L., Lampertico P., Ferrari C., Gentile I., Parruti G., Baiocchi L., Ciancio A., Invernizzi P., Federico A., Torti C., Morsica G., Andreone P., Aghemo A., Popoli P., Vella S., Kondili, L, Quaranta, M, Cavalletto, L, Calvaruso, V, Ferrigno, L, D'Ambrosio, R, Simonelli, I, Brancaccio, G, Raimondo, G, Brunetto, M, Zignego, A, Coppola, C, Iannone, A, Biliotti, E, Verucchi, G, Massari, M, Licata, A, Barbaro, F, Persico, M, Russo, F, Morisco, F, Pompili, M, Vigano, M, Puoti, M, Santantonio, T, Villa, E, Craxi, A, Chemello, L, Panetta, V, Gaeta, G, Filomia, R, Coco, B, Monti, M, Amoruso, D, Madonia, S, Ieluzzi, D, Taliani, G, Badia, L, Migliorino, G, Giorgini, A, Masarone, M, Blanc, P, Cossiga, V, De Siena, M, Tata, X, Rumi, M, Chessa, L, Lampertico, P, Ferrari, C, Gentile, I, Parruti, G, Baiocchi, L, Ciancio, A, Invernizzi, P, Federico, A, Torti, C, Morsica, G, Andreone, P, Aghemo, A, Popoli, P, Vella, S, Kondili L. A., Quaranta M. G., Cavalletto L., Calvaruso V., Ferrigno L., D'Ambrosio R., Simonelli I., Brancaccio G., Raimondo G., Brunetto M. R., Zignego A. L., Coppola C., Iannone A., Biliotti E., Verucchi G., Massari M., Licata A., Barbaro F., Persico M., Russo F. P., Morisco F., Pompili M., Vigano M., Puoti M., Santantonio T., Villa E., Craxi A., Chemello L., Panetta V., Gaeta G. B., Filomia R., Coco B., Monti M., Amoruso D. C., Madonia S., Ieluzzi D., Taliani G., Badia L., Migliorino G. M., Giorgini A., Masarone M., Blanc P., Cossiga V., De Siena M., Tata X., Rumi M. G., Chessa L., Lampertico P., Ferrari C., Gentile I., Parruti G., Baiocchi L., Ciancio A., Invernizzi P., Federico A., Torti C., Morsica G., Andreone P., Aghemo A., Popoli P., and Vella S.

Abstract

Background and aims: Severe liver disease markers assessed before HCV eradication are acknowledged to usually improve after the SVR. We prospectively evaluated, in the PITER cohort, the long-term HCC risk profile based on predictors monitored after HCV eradication by direct-acting antivirals in patients with cirrhosis. Methods: HCC occurrence was evaluated by Kaplan-Meier analysis. Cox regression analysis identified the post-treatment variables associated with de-novo HCC; their predictive power was presented in a nomogram. Results: After the end of therapy (median follow-up:28.47 months), among 2064 SVR patients, 119 (5.8%) developed de-novo HCC. The HCC incidence was 1.90%, 4.21%, 6.47% at 12-, 24- and 36-months from end-of-therapy, respectively (incidence rate 2.45/100 person-years). Age, genotype 3, diabetes, platelets (PLT)≤120,000/µl and albumin ≤3.5g/dl levels were identified as pre-treatment HCC independent predictors. Adjusting for age, the post-treatment PLT≤120,000/µl (AdjHR 1.92; 95%CI:1.06-3.45) and albumin≤3.5g/dl (AdjHR 4.38; 95%CI 2.48-7.75) values were independently associated with HCC occurrence. Two different risk profiles were identified by combining long-term post-therapy evaluation of PLT ≤ vs. >120,000/µl and albumin ≤ vs. >3.5g/dl showing a significant different HCC incidence rate of 1.35 vs. 3.77/100 p-y, respectively. Conclusions: The nomogram score based on age, PLT and albumin levels after SVR showed an accurate prediction capability and may support the customizing management for early HCC detection.

Published
2023

6. Serological and Molecular Characterization of Hepatitis C Virus-Related Cryoglobulinemic Vasculitis in Patients without Cryoprecipitate

Author

Napodano, Cecilia, Ciasca, Gabriele, Chiusolo, Patrizia, Pocino, Krizia, Gragnani, L., Stefanile, A., Gulli, F., Lorini, S., Minnella, Gessica, Fosso, F., Di Santo, R., Romanò, S., Basile, V., De Stefano, Valerio, Rapaccini, Gian Ludovico, Zignego, A. L., Di Stasio, Enrico, Marino, Mariapaola, Basile, Umberto, Napodano C. (ORCID:0000-0002-8720-6284), Ciasca G. (ORCID:0000-0002-3694-8229), Chiusolo P. (ORCID:0000-0002-1355-1587), Pocino K. (ORCID:0000-0003-2456-5308), Minnella G., De Stefano V. (ORCID:0000-0002-5178-5827), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Stasio E. (ORCID:0000-0003-1047-4261), Marino M. (ORCID:0000-0001-9155-6378), Basile U., Napodano, Cecilia, Ciasca, Gabriele, Chiusolo, Patrizia, Pocino, Krizia, Gragnani, L., Stefanile, A., Gulli, F., Lorini, S., Minnella, Gessica, Fosso, F., Di Santo, R., Romanò, S., Basile, V., De Stefano, Valerio, Rapaccini, Gian Ludovico, Zignego, A. L., Di Stasio, Enrico, Marino, Mariapaola, Basile, Umberto, Napodano C. (ORCID:0000-0002-8720-6284), Ciasca G. (ORCID:0000-0002-3694-8229), Chiusolo P. (ORCID:0000-0002-1355-1587), Pocino K. (ORCID:0000-0003-2456-5308), Minnella G., De Stefano V. (ORCID:0000-0002-5178-5827), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Stasio E. (ORCID:0000-0003-1047-4261), Marino M. (ORCID:0000-0001-9155-6378), and Basile U.

Abstract

Prolonged B cells stimulation due to the Hepatitis C virus (HCV) can result in autoimmunity, stigmatized by rising levels of cryoglobulins (CGs), the rheumatoid factor (RF), and free light chains (FLC) of immunoglobulins (Ig) associated with a range of symptoms, from their absence to severe cryoglobulinemic vasculitis and lymphoma. Here, we aimed to identify an immunological signature for the earliest stages of vasculitis when cryoprecipitate is still not detectable. We firstly analyzed the IgG subclasses, FLC, and RF in 120 HCV-RNA-positive patients divided into four groups according to the type of cryoprecipitate and symptoms: 30 asymptomatic without cryoprecipitate (No Cryo), 30 with vasculitis symptoms but without CGs that we supposed were circulating but still not detectable (Circulating), 30 type II and 30 type III mixed cryoglobulinemia (Cryo II and Cryo III, respectively). Our results revealed that patients with supposed circulating CGs displayed a pattern of serological parameters that closely resembled Cryo II and Cryo III, with a stronger similarity to Cryo II. Accordingly, we analyzed the groups of Circulating and Cryo II for their immunoglobulin heavy chain (IgH) and T-cell receptor (TCR) gene rearrangements, finding a similar mixed distribution of monoclonal, oligoclonal, and polyclonal responses compared to a control group of ten HCV-RNA-negative patients recovered from infection, who displayed a 100% polyclonal response. Our results strengthened the hypothesis that circulating CGs are the origin of symptoms in HCV-RNA-positive patients without cryoprecipitate and demonstrated that an analysis of clonal IGH and TCR rearrangements is the best option for the early diagnosis of extrahepatic complications.

Published
2023

7. Management of mixed cryoglobulinemia with rituximab: evidence and consensus-based recommendations from the Italian Study Group of Cryoglobulinemia (GISC)

Author

Quartuccio, L, Bortoluzzi, A, Scire, C, Marangoni, A, Del Frate, G, Treppo, E, Castelnovo, L, Saccardo, F, Zani, R, Candela, M, Fraticelli, P, Mazzaro, C, Renoldi, P, Scaini, P, Filippini, D, Visentini, M, Scarpato, S, Giuggioli, D, Mascia, M, Sebastiani, M, Zignego, A, Lauletta, G, Fiorilli, M, Casato, M, Ferri, C, Pietrogrande, M, Pioltelli, P, De Vita, S, Monti, G, Galli, M, Quartuccio L., Bortoluzzi A., Scire C. A., Marangoni A., Del Frate G., Treppo E., Castelnovo L., Saccardo F., Zani R., Candela M., Fraticelli P., Mazzaro C., Renoldi P., Scaini P., Filippini D. A., Visentini M., Scarpato S., Giuggioli D., Mascia M. T., Sebastiani M., Zignego A. L., Lauletta G., Fiorilli M., Casato M., Ferri C., Pietrogrande M., Pioltelli P. E., De Vita S., Monti G., Galli M., Quartuccio, L, Bortoluzzi, A, Scire, C, Marangoni, A, Del Frate, G, Treppo, E, Castelnovo, L, Saccardo, F, Zani, R, Candela, M, Fraticelli, P, Mazzaro, C, Renoldi, P, Scaini, P, Filippini, D, Visentini, M, Scarpato, S, Giuggioli, D, Mascia, M, Sebastiani, M, Zignego, A, Lauletta, G, Fiorilli, M, Casato, M, Ferri, C, Pietrogrande, M, Pioltelli, P, De Vita, S, Monti, G, Galli, M, Quartuccio L., Bortoluzzi A., Scire C. A., Marangoni A., Del Frate G., Treppo E., Castelnovo L., Saccardo F., Zani R., Candela M., Fraticelli P., Mazzaro C., Renoldi P., Scaini P., Filippini D. A., Visentini M., Scarpato S., Giuggioli D., Mascia M. T., Sebastiani M., Zignego A. L., Lauletta G., Fiorilli M., Casato M., Ferri C., Pietrogrande M., Pioltelli P. E., De Vita S., Monti G., and Galli M.

Abstract

Cryoglobulinemic vasculitis (CV) or mixed cryoglobulinemic syndrome (MCS) is a systemic small-vessel vasculitis characterized by the proliferation of B-cell clones producing pathogenic immune complexes, called cryoglobulins. It is often secondary to hepatitis C virus (HCV), autoimmune diseases, and hematological malignancies. CV usually has a mild benign clinical course, but severe organ damage and life-threatening manifestations can occur. Recently, evidence in favor of rituximab (RTX), an anti-CD 20 monoclonal antibody, is emerging in CV: nevertheless, questions upon the safety of this therapeutic approach, especially in HCV patients, are still being issued and universally accepted recommendations that can help physicians in MCS treatment are lacking. A Consensus Committee provided a prioritized list of research questions to perform a systematic literature review (SLR). A search was made in Medline, Embase, and Cochrane library, updated to August 2021. Of 1227 article abstracts evaluated, 27 studies were included in the SLR, of which one SLR, 4 RCTs, and 22 observational studies. Seventeen recommendations for the management of mixed cryoglobulinemia with rituximab from the Italian Study Group of Cryoglobulinemia (GISC) were developed to give a valuable tool to the physician approaching RTX treatment in CV.

Published
2023

8. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., Aghemo A., Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., and Aghemo A.

Abstract

Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy. Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used. Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P <0.0001) and that of anti-hepatitis D virus (HDV) remained stable (9.3% vs 8.3%). In both cohorts, about 25% of the patients had cirrhosis, and those in the PITER cohort were older. HBeAg-positive was 5.0% vs 12.6% (P <0.0001) and anti-HDV positive 24.8% vs 17.5% (P <0.0017). In the logistic model, the variables associated with cirrhosis were anti-HDV-positive (odds ratio = 10.08; confidence interval 7.63-13.43), age, sex, and body mass index; the likelihood of cirrhosis was reduced by 40% in the PITER cohort. Among non-Italians, 12.3% were HBeAg-positive (vs 23.4% in the MASTER cohort; P <0.0001), and 12.3% were anti-HDV-positive (vs 11.1%). Overall, the adherence to the European Association for the Study of the Liver recommendations for antiviral treatment increased over time. Conclusion: Chronic hepatitis B virus infection appears to be in the process of becoming under control in Italy; however, HDV infection is still a health concern in patients with cirrhosis and in migrants.

Published
2023

9. Impact of COVID-19 and vaccination campaign on 1,755 systemic sclerosis patients during first three years of pandemic. Possible risks for individuals with impaired immunoreactivity to vaccine, ongoing immunomodulating treatments, and disease-related lung involvement during the next pandemic phase

Author

Ferri, C., Raimondo, V., Giuggioli, D., Gragnani, L., Lorini, S., Dagna, L., Bosello, Silvia Laura, Foti, R., Riccieri, V., Guiducci, S., Cuomo, G., Tavoni, A., De Angelis, R., Cacciapaglia, F., Zanatta, E., Cozzi, F., Murdaca, G., Cavazzana, I., Romeo, N., Codullo, V., Pellegrini, R., Varcasia, G., De Santis, M., Selmi, C., Abignano, G., Caminiti, M., L'Andolina, M., Olivo, D., Lubrano, E., Spinella, A., Lumetti, F., De Luca, G., Ruscitti, P., Urraro, T., Visentini, M., Bellando-Randone, S., Visalli, E., Testa, D., Sciascia, G., Masini, F., Pellegrino, G., Saccon, F., Balestri, E., Elia, G., Ferrari, S. M., Tonutti, A., Dall'Ara, F., Pagano Mariano, G., Pettiti, G., Zanframundo, G., Brittelli, R., Aiello, V., Dal Bosco, Y., Di Cola, I., Scorpiniti, D., Fusaro, E., Ferrari, T., Gigliotti, P., Campochiaro, C., Francioso, F., Iandoli, C., Caira, V., Zignego, A. L., D'Angelo, S., Franceschini, F., Matucci-Cerinic, M., Giacomelli, R., Doria, A., Santini, Stefano Angelo, Fallahi, P., Iannone, F., Antonelli, A., Bosello S. L. (ORCID:0000-0002-4837-447X), Santini S. A. (ORCID:0000-0003-1956-5899), Ferri, C., Raimondo, V., Giuggioli, D., Gragnani, L., Lorini, S., Dagna, L., Bosello, Silvia Laura, Foti, R., Riccieri, V., Guiducci, S., Cuomo, G., Tavoni, A., De Angelis, R., Cacciapaglia, F., Zanatta, E., Cozzi, F., Murdaca, G., Cavazzana, I., Romeo, N., Codullo, V., Pellegrini, R., Varcasia, G., De Santis, M., Selmi, C., Abignano, G., Caminiti, M., L'Andolina, M., Olivo, D., Lubrano, E., Spinella, A., Lumetti, F., De Luca, G., Ruscitti, P., Urraro, T., Visentini, M., Bellando-Randone, S., Visalli, E., Testa, D., Sciascia, G., Masini, F., Pellegrino, G., Saccon, F., Balestri, E., Elia, G., Ferrari, S. M., Tonutti, A., Dall'Ara, F., Pagano Mariano, G., Pettiti, G., Zanframundo, G., Brittelli, R., Aiello, V., Dal Bosco, Y., Di Cola, I., Scorpiniti, D., Fusaro, E., Ferrari, T., Gigliotti, P., Campochiaro, C., Francioso, F., Iandoli, C., Caira, V., Zignego, A. L., D'Angelo, S., Franceschini, F., Matucci-Cerinic, M., Giacomelli, R., Doria, A., Santini, Stefano Angelo, Fallahi, P., Iannone, F., Antonelli, A., Bosello S. L. (ORCID:0000-0002-4837-447X), and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Introduction: The impact of COVID-19 pandemic represents a serious challenge for ‘frail’ patients' populations with inflammatory autoimmune systemic diseases such as systemic sclerosis (SSc). We investigated the prevalence and severity of COVID-19, as well the effects of COVID-19 vaccination campaign in a large series of SSc patients followed for the entire period (first 38 months) of pandemic. Patients and method: This prospective survey study included 1755 unselected SSc patients (186 M, 1,569F; mean age 58.7 ± 13.4SD years, mean disease duration 8.8 ± 7.3SD years) recruited in part by telephone survey at 37 referral centers from February 2020 to April 2023. The following parameters were carefully evaluated: i. demographic, clinical, serological, and therapeutical features; ii. prevalence and severity of COVID-19; and iii. safety, immunogenicity, and efficacy of COVID-19 vaccines. Results: The prevalence of COVID-19 recorded during the whole pandemic was significantly higher compared to Italian general population (47.3 % vs 43.3 %, p < 0.000), as well the COVID-19-related mortality (1.91 % vs 0.72 %, p < 0.001). As regards the putative prognostic factors of worse outcome, COVID-19 positive patients with SSc-related interstitial lung involvement showed significantly higher percentage of COVID-19-related hospitalization compared to those without (5.85 % vs 1.73 %; p < 0.0001), as well as of mortality rate (2.01 % vs 0.4 %; p = 0.002). Over half of patients (56.3 %) received the first two plus one booster dose of vaccine; while a fourth dose was administered to 35.6 %, and only few of them (1.99 %) had five or more doses of vaccine. Of note, an impaired seroconversion was recorded in 25.6 % of individuals after the first 2 doses of vaccine, and in 8.4 % of patients also after the booster dose. Furthermore, the absence of T-cell immunoreactivity was observed in 3/7 patients tested by QuantiFERON® SARSCoV-2 Starter Set (Qiagen). The efficacy of vaccines, evalu

Published
2023

10. COVID-19 and Mixed Cryoglobulinemia Syndrome: Long-Term Survey Study on the Prevalence and Outcome, Vaccine Safety, and Immunogenicity

Author

Gragnani, L., Visentini, M., Lorini, S., Santini, Stefano Angelo, Lauletta, G., Mazzaro, C., Urraro, T., Quartuccio, L., Cacciapaglia, F., Ruscitti, P., Tavoni, A., Marri, S., Cusano, G., Petraccia, L., Naclerio, C., Treppo, E., del Frate, G., Di Cola, I., Raimondo, V., Scorpiniti, D., Monti, M., Puccetti, L., Elia, G., Fallahi, P., Basili, S., Scarpato, S., Iannone, F., Casato, M., Antonelli, A., Zignego, A. L., Ferri, C., Santini S. A. (ORCID:0000-0003-1956-5899), Gragnani, L., Visentini, M., Lorini, S., Santini, Stefano Angelo, Lauletta, G., Mazzaro, C., Urraro, T., Quartuccio, L., Cacciapaglia, F., Ruscitti, P., Tavoni, A., Marri, S., Cusano, G., Petraccia, L., Naclerio, C., Treppo, E., del Frate, G., Di Cola, I., Raimondo, V., Scorpiniti, D., Monti, M., Puccetti, L., Elia, G., Fallahi, P., Basili, S., Scarpato, S., Iannone, F., Casato, M., Antonelli, A., Zignego, A. L., Ferri, C., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Purpose: Mixed cryoglobulinemia syndrome (MCs) is a rare immunoproliferative systemic disorder with cutaneous and multiple organ involvement. Our multicenter survey study aimed to investigate the prevalence and outcome of COVID-19 and the safety and immunogenicity of COVID-19 vaccines in a large MCs series. Methods: The survey included 430 unselected MCs patients (130 M, 300 F; mean age 70 ± 10.96 years) consecutively collected at 11 Italian referral centers. Disease classification, clinico-serological assessment, COVID-19 tests, and vaccination immunogenicity were carried out according to current methodologies. Results: A significantly higher prevalence of COVID-19 was found in MCs patients compared to Italian general population (11.9% vs 8.0%, p < 0.005), and the use of immunomodulators was associated to a higher risk to get infected (p = 0.0166). Moreover, higher mortality rate was recorded in MCs with COVID-19 compared to those without (p < 0.01). Patients’ older age (≥ 60 years) correlated with worse COVID-19 outcomes. The 87% of patients underwent vaccination and 50% a booster dose. Of note, vaccine-related disease flares/worsening were significantly less frequent than those associated to COVID-19 (p = 0.0012). Impaired vaccination immunogenicity was observed in MCs patients compared to controls either after the first vaccination (p = 0.0039) and also after the booster dose (p = 0.05). Finally, some immunomodulators, namely, rituximab and glucocorticoids, hampered the vaccine-induced immunogenicity (p = 0.029). Conclusions: The present survey revealed an increased prevalence and morbidity of COVID-19 in MCs patients, as well an impaired immunogenicity even after booster vaccination with high rate of no response. Therefore, MCs can be included among frail populations at high risk of infection and severe COVID-19 manifestations, suggesting the need of a close monitoring and specific preventive/therapeutical measures during the ongoing pandemic.

Published
2023

13. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases

Author

Ferri, C., Gragnani, L., Raimondo, V., Visentini, M., Giuggioli, D., Lorini, S., Foti, R., Cacciapaglia, F., Caminiti, M., Olivo, D., Cuomo, G., Pellegrini, R., Pigatto, E., Urraro, T., Naclerio, C., Tavoni, A., Puccetti, L., Cavazzana, I., Ruscitti, P., Vadacca, M., La Gualana, F., Cozzi, F., Spinella, A., Visalli, E., Bosco, Y. D., Amato, G., Masini, F., Mariano, G. P., Brittelli, R., Aiello, V., Scorpiniti, D., Rechichi, G., Varcasia, G., Monti, M., Elia, G., Franceschini, F., Casato, M., Ursini, F., Giacomelli, R., Fallahi, P., Santini, Stefano Angelo, Iannone, F., Salvarani, C., Zignego, A. L., Antonelli, A., Santini S. A. (ORCID:0000-0003-1956-5899), Ferri, C., Gragnani, L., Raimondo, V., Visentini, M., Giuggioli, D., Lorini, S., Foti, R., Cacciapaglia, F., Caminiti, M., Olivo, D., Cuomo, G., Pellegrini, R., Pigatto, E., Urraro, T., Naclerio, C., Tavoni, A., Puccetti, L., Cavazzana, I., Ruscitti, P., Vadacca, M., La Gualana, F., Cozzi, F., Spinella, A., Visalli, E., Bosco, Y. D., Amato, G., Masini, F., Mariano, G. P., Brittelli, R., Aiello, V., Scorpiniti, D., Rechichi, G., Varcasia, G., Monti, M., Elia, G., Franceschini, F., Casato, M., Ursini, F., Giacomelli, R., Fallahi, P., Santini, Stefano Angelo, Iannone, F., Salvarani, C., Zignego, A. L., Antonelli, A., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Autoimmune systemic diseases (ASD) show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed at evaluating the seroconversion elicited by COVID-19 vaccine over the entire vaccination cycle including the booster dose. Among 478 unselected ASD patients originally evaluated at the end of the first vaccination cycle (time 1), 344 individuals were re-evaluated after a 6-month period (time 2), and 244 after the booster vaccine dose (time 3). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was assessed by measuring serum IgG-neutralizing antibody (NAb) on samples obtained at the three time points in both patients and 502 age-matched controls. In the 244 ASD group that received booster vaccine and monitored over the entire follow-up, the mean serum NAb levels (time 1, 2, and 3: 696.8 ± 52.68, 370.8 ± 41.92, and 1527 ± 74.16SD BAU/mL, respectively; p < 0.0001) were constantly lower compared to controls (p < 0.0001), but they significantly increased after the booster dose compared to the first two measurements (p < 0.0001). The percentage of patients with absent/suboptimal response to vaccine significantly decreased after the booster dose compared to the first and second evaluations (time 1, 2, and 3: from 28.2% to 46.3%, and to 7.8%, respectively; p < 0.0001). Of note, the percentage of patients with absent/suboptimal response after the booster dose was significantly higher compared to controls (19/244, 7.8% vs 1/502, 0.2%; p < 0.0001). Similarly, treatment with immune-modifiers increased the percentage of patients exhibiting absent/suboptimal response (16/122, 13.1% vs 3/122, 2.46%; p = 0.0031). Overall, the above findings indicate the usefulness of booster vaccine administration in ASD patients. Moreover, the persistence of a significantly higher percentage of individuals without effective seroconversion (7.8%), even after the booster dose, warrants for careful monitoring of NAb levels in a

Published
2022

14. Flares of mixed cryoglobulinaemia vasculitis after vaccination against SARS-CoV-2

Author

Visentini, M., Gragnani, L., Santini, Stefano Angelo, Urraro, T., Villa, A., Monti, M., Palladino, A., Petraccia, L., La Gualana, F., Lorini, S., Marri, S., Madia, F., Stefanini, L., Basili, S., Fiorilli, M., Ferri, C., Zignego, A. L., Casato, M., Santini S. A. (ORCID:0000-0003-1956-5899), Visentini, M., Gragnani, L., Santini, Stefano Angelo, Urraro, T., Villa, A., Monti, M., Palladino, A., Petraccia, L., La Gualana, F., Lorini, S., Marri, S., Madia, F., Stefanini, L., Basili, S., Fiorilli, M., Ferri, C., Zignego, A. L., Casato, M., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Studies on the safety and immunogenicity of SARS-CoV- 2 vaccination in patients with inflammatory rheumatic diseases have so far not included mixed cryoglobulinaemia (MC) vasculitis.1–3 We report a prospective observational multicentre study on this disorder.

Published
2022

15. A prospective study of direct-acting antiviral effectiveness and relapse risk in HCV cryoglobulinemic vasculitis by the Italian PITER cohort

Author

Kondili, L, Monti, M, Quaranta, M, Gragnani, L, Panetta, V, Brancaccio, G, Mazzaro, C, Persico, M, Masarone, M, Gentile, I, Andreone, P, Madonia, S, Biliotti, E, Filomia, R, Puoti, M, Fracanzani, A, Laccabue, D, Ieluzzi, D, Coppola, C, Rumi, M, Benedetti, A, Verucchi, G, Coco, B, Chemello, L, Iannone, A, Ciancio, A, Russo, F, Barbaro, F, Morisco, F, Chessa, L, Massari, M, Blanc, P, Zignego, A, Kondili L. A., Monti M., Quaranta M. G., Gragnani L., Panetta V., Brancaccio G., Mazzaro C., Persico M., Masarone M., Gentile I., Andreone P., Madonia S., Biliotti E., Filomia R., Puoti M., Fracanzani A. L., Laccabue D., Ieluzzi D., Coppola C., Rumi M. G., Benedetti A., Verucchi G., Coco B., Chemello L., Iannone A., Ciancio A., Russo F. P., Barbaro F., Morisco F., Chessa L., Massari M., Blanc P., Zignego A. L., Kondili, L, Monti, M, Quaranta, M, Gragnani, L, Panetta, V, Brancaccio, G, Mazzaro, C, Persico, M, Masarone, M, Gentile, I, Andreone, P, Madonia, S, Biliotti, E, Filomia, R, Puoti, M, Fracanzani, A, Laccabue, D, Ieluzzi, D, Coppola, C, Rumi, M, Benedetti, A, Verucchi, G, Coco, B, Chemello, L, Iannone, A, Ciancio, A, Russo, F, Barbaro, F, Morisco, F, Chessa, L, Massari, M, Blanc, P, Zignego, A, Kondili L. A., Monti M., Quaranta M. G., Gragnani L., Panetta V., Brancaccio G., Mazzaro C., Persico M., Masarone M., Gentile I., Andreone P., Madonia S., Biliotti E., Filomia R., Puoti M., Fracanzani A. L., Laccabue D., Ieluzzi D., Coppola C., Rumi M. G., Benedetti A., Verucchi G., Coco B., Chemello L., Iannone A., Ciancio A., Russo F. P., Barbaro F., Morisco F., Chessa L., Massari M., Blanc P., and Zignego A. L.

Abstract

Background and Aims: Mixed cryoglobulinemia is the most common HCV extrahepatic manifestation. We aimed to prospectively evaluate the cryoglobulinemic vasculitis (CV) clinical profile after a sustained virologic response (SVR) over a medium-term to long-term period. Approach and Results: Direct-acting antiviral–treated cryoglobulinemic patients, consecutively enrolled in the multicentric Italian Platform for the Study of Viral Hepatitis Therapy cohort, were prospectively evaluated. Cumulative incidence Kaplan-Meier curves were reported for response, clinical deterioration, relapse and relapse-free survival rates. Cox regression analysis evaluated factors associated with different outcomes. A clinical response was reported in at least one follow-up point for 373 of 423 (88%) patients with CV who achieved SVR. Clinical response increased over time with a 76% improvement rate at month 12 after the end of treatment. A full complete response (FCR) was reached by 164 (38.8%) patients in at least one follow-up point. CV clinical response fluctuated, with some deterioration of the initial response in 49.6% of patients (median time of deterioration, 19 months). In patients who achieved FCR and had an available follow-up (137 patients) a relapse was observed in 13% and it was transient in 66.7% of patients. The rate of patients without any deterioration was 58% and 41% at 12 and 24 months, respectively. After achieving SVR, a clinical nonresponse was associated with older age and renal involvement; a clinical deterioration/relapse was associated with high pretreatment rheumatoid factor values, and FCR was inversely associated with age, neuropathy, and high cryocrit levels. Conclusion: In patients with CV, HCV eradication may not correspond to a persistent clinical improvement, and clinical response may fluctuate. This implies an attentive approach to post-SVR evaluation through prognostic factors and tailored treatment.

Published
2022

17. POS1214 COVID-19 VACCINATION RATE AND SAFETY PROFILE IN PATIENTS AFFECTED BY MIXED CRYOGLOBULINEMIC VASCULITIS.

Author

Vacchi, C., primary, Testoni, S., additional, Visentini, M., additional, Zani, R., additional, Lauletta, G., additional, Gragnani, L., additional, Filippini, D. A., additional, Mazzaro, C., additional, Fraticelli, P., additional, Quartuccio, L., additional, Padoan, R., additional, Castelnovo, L., additional, Zignego, A. L., additional, Ferri, C., additional, Hoxha, A., additional, Salvarani, C., additional, Monti, G., additional, Galli, M., additional, and Sebastiani, M., additional

Published
2022
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18. POS1267 LONG-TERM SURVEY STUDY OF THE IMPACT OF COVID-19 ON SYSTEMIC AUTOIMMUNE DISEASES. LOW DEATH RATE DESPITE THE INCREASED PREVALENCE OF SYMPTOMATIC INFECTION. ROLE OF PRE-EXISTING INTERSTITIAL LUNG DISEASE AND ONGOING TREATMENTS.

Author

Ferri, C., primary, Raimondo, V., additional, Gragnani, L., additional, Giuggioli, D., additional, Dagna, L., additional, Tavoni, A., additional, Ursini, F., additional, L’andolina, M., additional, Caso, F., additional, Ruscitti, P., additional, Caminiti, M., additional, Foti, R., additional, Riccieri, V., additional, Guiducci, S., additional, Pellegrini, R., additional, Zanatta, E., additional, Varcasia, G., additional, Olivo, D., additional, Gigliotti, P., additional, Cuomo, G., additional, Murdaca, G., additional, Cecchetti, R., additional, De Angelis, R., additional, Romeo, N., additional, Ingegnoli, F., additional, Cozzi, F., additional, Codullo, V., additional, Cavazzana, I., additional, Colaci, M., additional, Abignano, G., additional, De Santis, M., additional, Lubrano, E., additional, Fusaro, E., additional, Spinella, A., additional, Lumetti, F., additional, De Luca, G., additional, Bellando Randone, S., additional, Visalli, E., additional, Dal Bosco, Y., additional, Amato, G., additional, Giannini, D., additional, Bilia, S., additional, Masini, F., additional, Pellegrino, G., additional, Pigatto, E., additional, Generali, E., additional, Pagano Mariano, G., additional, Pettiti, G., additional, Zanframundo, G., additional, Brittelli, R., additional, Aiello, V., additional, Caminiti, R., additional, Scorpiniti, D., additional, Ferrari, T., additional, Campochiaro, C., additional, Brusi, V., additional, Fredi, M., additional, Moschetti, L., additional, Cacciapaglia, F., additional, Ferrari, S. M., additional, DI Cola, I., additional, Vadacca, M., additional, Lorusso, S., additional, Monti, M., additional, Lorini, S., additional, Paparo, S. R., additional, Ragusa, F., additional, Elia, G., additional, Mazzi, V., additional, Aprile, M. L., additional, Tasso, M., additional, Miccoli, M., additional, Bosello, S. L., additional, D’angelo, S., additional, Doria, A., additional, Franceschini, F., additional, Meliconi, R., additional, Matucci-Cerinic, M., additional, Iannone, F., additional, Giacomelli, R., additional, Salvarani, C., additional, Zignego, A. L., additional, Fallahi, P., additional, and Antonelli, A., additional

Published
2022
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21. Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program

Author

Bruno, S., Bollani, S., Zignego, A. L., Pascasio, J. M., Magni, C., Ciancio, A., Caremani, M., Mangia, A., Marenco, S., Piovesan, S., Chemello, L., Babudieri, S., Moretti, A., Gea, F., Colletta, C., Perez-Alvarez, R., Forns, X., Larrubia, J. R., Arenas, J., Crespo, J., Calvaruso, V., Silberstein, Ceccherini F., Maisonneuve, P., Craxì, A., and Calleja, J. L.

Published
2015
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22. DIRECT‐ACTING ANTIVIRALS AS PRIMARY TREATMENT FOR HCV‐ASSOCIATED INDOLENT NON‐HODGKIN LYMPHOMAS: THE PROSPECTIVE BART STUDY OF THE FONDAZIONE ITALIANA LINFOMI

Author

Merli, M., primary, Rattotti, S., additional, Spina, M., additional, Re, F., additional, Motta, M., additional, Piazza, F., additional, Orsucci, L., additional, Ferreri, Andrés J.M., additional, Perbellini, O., additional, Dodero, A., additional, Vallisa, D., additional, Pulsoni, A., additional, Santoro, A., additional, Zuccaro, V., additional, Chimienti, E., additional, Russo, F., additional, Visco, C., additional, Zignego, A. L., additional, Marcheselli, L., additional, Luminari, S., additional, Paulli, M., additional, Bruno, R., additional, and Arcaini, L., additional

Published
2021
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23. SARS-CoV-2 was already circulating in Italy, in early December 2019

Author

Gragnani, L., Monti, M., Santini, Stefano Angelo, Marri, S., Madia, F., Lorini, S., Petraccia, L., Stasi, C., Basile, Umberto, Luti, V., Pagliai, F., Saccardi, R., Zignego, A. L., Santini S. A. (ORCID:0000-0003-1956-5899), Basile U., Gragnani, L., Monti, M., Santini, Stefano Angelo, Marri, S., Madia, F., Lorini, S., Petraccia, L., Stasi, C., Basile, Umberto, Luti, V., Pagliai, F., Saccardi, R., Zignego, A. L., Santini S. A. (ORCID:0000-0003-1956-5899), and Basile U.

Abstract

– OBJECTIVE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identified in China, in December 2019 determines COronaVIrus Disease 19 (COVID-19). Whether or not the virus was present in Italy earlier the first autochthonous COVID-19 case was diagnosed is still uncertain. We aimed to identify anti-SARS-CoV-2 antibodies in sera collected from 4th November 2019 to 9th March 2020, in order to assess the possible spread of the virus in Italy earlier than the first official national diagnosis. PATIENTS AND METHODS: Anti-SARS-CoV-2 antibodies were evaluated in retrospective serum samples from 234 patients with liver diseases (Hep-patients) and from 56 blood donors (BDs). We used two rapid serologic tests which were confirmed by a validated chemoluminescence assay. RESULTS: Via rapid tests, we found 10/234 (4.3%) IgG-positive and 1/234 (0.4%) IgM-positive cases in the Hep-patient group. Two/56 (3.6%) IgG-positive and 2/56 (3.6%) IgM-positive cases were detected in BD group. Chemoluminescence confirmed IgG-positivity in 3 Hep-patients and 1 BD and IgM-positivity in 1 Hep-patient. RNAemia was not detected in any of the subjects, rendering the risk of transfusion transmission negligible. CONCLUSIONS: Our results suggest an early circulation of SARS-CoV-2 in Italy, before the first COVID-19 cases were described in China. Rapid tests have multiple benefits; however, a confirmation assay is required to avoid false positive results.

Published
2021

24. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups

Author

Ferri, C., Ursini, F., Gragnani, L., Raimondo, V., Giuggioli, D., Foti, R., Caminiti, M., Olivo, D., Cuomo, G., Visentini, M., Cacciapaglia, F., Pellegrini, R., Pigatto, E., Urraro, T., Naclerio, C., Tavoni, A., Puccetti, L., Varcasia, G., Cavazzana, I., L'Andolina, M., Ruscitti, P., Vadacca, M., Gigliotti, P., La Gualana, F., Cozzi, F., Spinella, A., Visalli, E., Dal Bosco, Y., Amato, G., Masini, F., Pagano Mariano, G., Brittelli, R., Aiello, V., Caminiti, R., Scorpiniti, D., Rechichi, G., Ferrari, T., Monti, M., Elia, G., Franceschini, F., Meliconi, R., Casato, M., Iannone, F., Giacomelli, R., Fallahi, P., Santini, Stefano Angelo, Zignego, A. L., Antonelli, A., Santini S. A. (ORCID:0000-0003-1956-5899), Ferri, C., Ursini, F., Gragnani, L., Raimondo, V., Giuggioli, D., Foti, R., Caminiti, M., Olivo, D., Cuomo, G., Visentini, M., Cacciapaglia, F., Pellegrini, R., Pigatto, E., Urraro, T., Naclerio, C., Tavoni, A., Puccetti, L., Varcasia, G., Cavazzana, I., L'Andolina, M., Ruscitti, P., Vadacca, M., Gigliotti, P., La Gualana, F., Cozzi, F., Spinella, A., Visalli, E., Dal Bosco, Y., Amato, G., Masini, F., Pagano Mariano, G., Brittelli, R., Aiello, V., Caminiti, R., Scorpiniti, D., Rechichi, G., Ferrari, T., Monti, M., Elia, G., Franceschini, F., Meliconi, R., Casato, M., Iannone, F., Giacomelli, R., Fallahi, P., Santini, Stefano Angelo, Zignego, A. L., Antonelli, A., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53–1203) vs 825 (451–1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subje

Published
2021

25. Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Author

Aghemo, A., Alberti, A., Andreone, P., Angelico, M., Brunetto, M. R., Chessa, L., Ciancio, A., Craxi, A., Gaeta, G. B., Galli, M., Gasbarrini, A., Giorgini, A., Grilli, E., Lampertico, P., Lichtner, M., Milella, M., Morisco, F., Persico, M., Pirisi, M., Puoti, M., Raimondo, G., Romano, A., Russello, M., Sangiovanni, V., Schiavini, M., Serviddio, G., Villa, E., Vinci, M., De Michina, A., Gallinaro, V., Gualberti, G., Roscini, A. S., Zignego, A. L., Alberti A., Gasbarrini A. (ORCID:0000-0002-7278-4823), Vinci M., Aghemo, A., Alberti, A., Andreone, P., Angelico, M., Brunetto, M. R., Chessa, L., Ciancio, A., Craxi, A., Gaeta, G. B., Galli, M., Gasbarrini, A., Giorgini, A., Grilli, E., Lampertico, P., Lichtner, M., Milella, M., Morisco, F., Persico, M., Pirisi, M., Puoti, M., Raimondo, G., Romano, A., Russello, M., Sangiovanni, V., Schiavini, M., Serviddio, G., Villa, E., Vinci, M., De Michina, A., Gallinaro, V., Gualberti, G., Roscini, A. S., Zignego, A. L., Alberti A., Gasbarrini A. (ORCID:0000-0002-7278-4823), and Vinci M.

Abstract

Background and Aims: The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods: Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results: The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion: Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.

Published
2021

26. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author

Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, Francesca Bice, Massari, Massimo, Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, Federico, Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, Marco, Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, Marco, Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, Rosa Anna, Mondelli, M., Chessa, L., Loi, M., Torti, Carlo, Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, Enrico Maria, Zignego, A. L., Monti, M., Madia, Francesca, Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, Roberto, Lampertico, P., Borghi, Margherita, D'Ambrosio, Roberto, Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, Maria Rosaria, Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, Luca, Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, Francesco, Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, Simone, Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, Maria Chiara, Bruno, E. M., Licata, Maria Angela Vittoria Anna Chiara, Amodeo, Silvia, Capitano, A. R., Ferrari, C., Negri, Erica, Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, Luca, Grassi, G., Gasbarrini, Antonio, Pompili, Maurizio, Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, Monia, Saracco, G. M., D'Angelo F., Massari M. (ORCID:0000-0001-7048-6374), Barbaro F., Cucco M., Rendina M., Bruno R., Torti C., Trecarichi E. M., Madia F., Lombardi R., Borghi M., D'ambrosio R., Vinci M., Bristot L., Pisano F., Martini S., Cannizzaro M., Licata A., Amodeo S., Negri E., Baiocchi L., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pompili M. (ORCID:0000-0001-6699-7980), Marturano M., Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, Francesca Bice, Massari, Massimo, Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, Federico, Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, Marco, Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, Marco, Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, Rosa Anna, Mondelli, M., Chessa, L., Loi, M., Torti, Carlo, Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, Enrico Maria, Zignego, A. L., Monti, M., Madia, Francesca, Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, Roberto, Lampertico, P., Borghi, Margherita, D'Ambrosio, Roberto, Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, Maria Rosaria, Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, Luca, Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, Francesco, Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, Simone, Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, Maria Chiara, Bruno, E. M., Licata, Maria Angela Vittoria Anna Chiara, Amodeo, Silvia, Capitano, A. R., Ferrari, C., Negri, Erica, Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, Luca, Grassi, G., Gasbarrini, Antonio, Pompili, Maurizio, Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, Monia, Saracco, G. M., D'Angelo F., Massari M. (ORCID:0000-0001-7048-6374), Barbaro F., Cucco M., Rendina M., Bruno R., Torti C., Trecarichi E. M., Madia F., Lombardi R., Borghi M., D'ambrosio R., Vinci M., Bristot L., Pisano F., Martini S., Cannizzaro M., Licata A., Amodeo S., Negri E., Baiocchi L., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pompili M. (ORCID:0000-0001-6699-7980), and Marturano M.

Abstract

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.

Published
2021

27. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author

Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta M. G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P. L., Margotti M., Ieluzzi D., Brunetto M. R., Barbaro F., Russo F. P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L. A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A. D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E. M., Zignego A. L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T. A., Bruno S. R., Cela E. M., Bassetti M., Mazzarello G., Alessandrini A. I., Biagio A. D., Nicolini L. A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A. L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M. G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M. L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D. C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A. R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E. M., Licata A., Amodeo S., Capitano A. R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P. D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M. D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P. D., Marturano M., Saracco G. M., Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta M. G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P. L., Margotti M., Ieluzzi D., Brunetto M. R., Barbaro F., Russo F. P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L. A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A. D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E. M., Zignego A. L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T. A., Bruno S. R., Cela E. M., Bassetti M., Mazzarello G., Alessandrini A. I., Biagio A. D., Nicolini L. A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A. L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M. G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M. L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D. C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A. R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E. M., Licata A., Amodeo S., Capitano A. R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P. D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M. D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P. D., Marturano M., and Saracco G. M.

Abstract

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.

Published
2021

28. Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Author

Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, M, Chessa, L, Ciancio, A, Craxi, A, Gaeta, G, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, A, Zignego, A, Aghemo A., Alberti A., Andreone P., Angelico M., Brunetto M. R., Chessa L., Ciancio A., Craxi A., Gaeta G. B., Galli M., Gasbarrini A., Giorgini A., Grilli E., Lampertico P., Lichtner M., Milella M., Morisco F., Persico M., Pirisi M., Puoti M., Raimondo G., Romano A., Russello M., Sangiovanni V., Schiavini M., Serviddio G., Villa E., Vinci M., De Michina A., Gallinaro V., Gualberti G., Roscini A. S., Zignego A. L., Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, M, Chessa, L, Ciancio, A, Craxi, A, Gaeta, G, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, A, Zignego, A, Aghemo A., Alberti A., Andreone P., Angelico M., Brunetto M. R., Chessa L., Ciancio A., Craxi A., Gaeta G. B., Galli M., Gasbarrini A., Giorgini A., Grilli E., Lampertico P., Lichtner M., Milella M., Morisco F., Persico M., Pirisi M., Puoti M., Raimondo G., Romano A., Russello M., Sangiovanni V., Schiavini M., Serviddio G., Villa E., Vinci M., De Michina A., Gallinaro V., Gualberti G., Roscini A. S., and Zignego A. L.

Abstract

Background and Aims: The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods: Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results: The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (318/319) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion: Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.

Published
2021

29. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author

Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo

Subjects
Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract

OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.\ud \ud RESULTS:\ud The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.\ud \ud CONCLUSIONS:\ud This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

Published
2019

32. A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis

Author

De Vita, S., Quartuccio, L., Isola, M., Mazzaro, C., Scaini, P., Lenzi, M., Campanini, M., Naclerio, C., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Masolini, P., Zabotti, A., Maset, M., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., Filippini, D., Perrella, O., Migliaresi, S., Galli, M., Bombardieri, S., and Monti, G.

Published
2012
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34. Preliminary classification criteria for the cryoglobulinaemic vasculitis

Author

De Vita, S, Soldano, F, Isola, M, Monti, G, Gabrielli, A, Tzioufas, A, Ferri, C, Ferraccioli, G F, Quartuccio, L, Corazza, L, De Marchi, G, Casals, M Ramos, Voulgarelis, M, Lenzi, M, Saccardo, F, Fraticelli, P, Mascia, M T, Sansonno, D, Cacoub, P, Tomsic, M, Tavoni, A, Pietrogrande, M, Zignego, A L, Scarpato, S, Mazzaro, C, Pioltelli, P, Steinfeld, S, Lamprecht, P, Bombardieri, S, and Galli, M

Published
2011
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38. A novel biomarker score for the screening and management of patients with plasma cell proliferative disorders

Author

Basile, U., Gulli, F., Isgro, M. A., Napodano, C., Pocino, K., Santini, S. A., Gragnani, L., Conti, L., Rossi, E., Cordone, I., Zignego, A. L., Rapaccini, G. L., Cigliana, G., Berruti, Franco, Todi, L., Marino, M., and Di Stasio, E.

Subjects
B-cell non-Hodgkin's lymphoma, Biomarker, Free Light Chains, HCV, Mixed Cryoglobulinemia, Monoclonal Gammopathy, Multiple myeloma, sCD138, immune system diseases, hemic and lymphatic diseases
Published
2019

42. Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN)

Author

Minutolo, R, Aghemo, A, Chirianni, A, Fabrizi, F, Gesualdo, L, Giannini, E, Maggi, P, Montinaro, V, Paoletti, E, Persico, M, Perticone, F, Petta, S, Puoti, M, Raimondo, G, Rendina, M, Zignego, A, Minutolo R., Aghemo A., Chirianni A., Fabrizi F., Gesualdo L., Giannini E. G., Maggi P., Montinaro V., Paoletti E., Persico M., Perticone F., Petta S., Puoti M., Raimondo G., Rendina M., Zignego A. L., Minutolo, R, Aghemo, A, Chirianni, A, Fabrizi, F, Gesualdo, L, Giannini, E, Maggi, P, Montinaro, V, Paoletti, E, Persico, M, Perticone, F, Petta, S, Puoti, M, Raimondo, G, Rendina, M, Zignego, A, Minutolo R., Aghemo A., Chirianni A., Fabrizi F., Gesualdo L., Giannini E. G., Maggi P., Montinaro V., Paoletti E., Persico M., Perticone F., Petta S., Puoti M., Raimondo G., Rendina M., and Zignego A. L.

Abstract

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.

Published
2019

43. Real life experiences in HCV management in 2018

Author

Vigano, M, Andreoni, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Babudieri, S, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Cartabellotta, F, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Coppola, N, Di Marco, V, Di Perri, G, Fagiuoli, S, Gaeta, G, Gasbarrini, A, Lampertico, P, Pellicelli, A, Prestileo, T, Puoti, M, Raimondo, G, Rizzardini, G, Taliani, G, Zignego, A, Vigano M., Andreoni M., Perno C. F., Craxi A., Aghemo A., Alberti A., Andreone P., Babudieri S., Bonora S., Brunetto M. R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Cartabellotta F., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Coppola N., Di Marco V., Di Perri G., Fagiuoli S., Gaeta G. B., Gasbarrini A., Lampertico P., Pellicelli A., Prestileo T., Puoti M., Raimondo G., Rizzardini G., Taliani G., Zignego A. L., Vigano, M, Andreoni, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Babudieri, S, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Cartabellotta, F, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Coppola, N, Di Marco, V, Di Perri, G, Fagiuoli, S, Gaeta, G, Gasbarrini, A, Lampertico, P, Pellicelli, A, Prestileo, T, Puoti, M, Raimondo, G, Rizzardini, G, Taliani, G, Zignego, A, Vigano M., Andreoni M., Perno C. F., Craxi A., Aghemo A., Alberti A., Andreone P., Babudieri S., Bonora S., Brunetto M. R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Cartabellotta F., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Coppola N., Di Marco V., Di Perri G., Fagiuoli S., Gaeta G. B., Gasbarrini A., Lampertico P., Pellicelli A., Prestileo T., Puoti M., Raimondo G., Rizzardini G., Taliani G., and Zignego A. L.

Abstract

Introduction: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Treatment of chronic hepatitis C has considerably improved in the last few years thanks to the introduction of direct-acting antivirals able to achieve sustained virological response in more than 95% of patients. Successful anti-HCV treatment can halt liver disease progression and solve the HCV-related extra-hepatic manifestations, eventually reducing liver-related and overall mortality. Areas covered: With the aim to respond to unmet needs in patient’s identification, universal access to antiviral therapy and treatment optimization in specific setting of HCV-infected patients, a group of Italian experts met in Stresa in May 2018. The summary of the considerations arising from this meeting and the final statements are reported in this paper. Expert commentary: All the advances on HCV cure may have a real clinical impact not only in individual patients but also at the social health level if they are applied to all infected patients, independently from the stage of liver disease. Further improvements are needed in order to attain HCV elimination, such as the development of an enhanced screening program working in parallel to the present treatment options.

Published
2019

44. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author

Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., Ieluzzi D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., and Ieluzzi D.

Abstract

Objective: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. Methods: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. Results: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. Conclusions: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

Published
2019

45. Cryoglobulins

Author

Ferri, C, Zignego, A L, and Pileri, S A

Published
2002

46. Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV

Author

Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Federico, A., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou, A., Han, X., Kondili, L., Taliani, G., Ciancio, A., Morisco, F., Critelli, R., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A., Bruno, S., Bao, Y., Gonzalez, Y., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Pasetto, M.C., Capitano, A.R., Zignego, A.L., Russo, F.P., Amoruso, D.C., Gaeta, G.B., Weimer, L.E., Quaranta, M.G., Craxã¬, A., and Federico, A.

Subjects
Anti-Mullerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, Hepatology, Infertility, medicine.medical_specialty, media_common.quotation_subject, Fertility, Anti-Müllerian hormone, Miscarriage, 03 medical and health sciences, 0302 clinical medicine, Medicine, Prospective cohort study, media_common, Gynecology, Anti-Müllerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, medicine.disease, Anti-Müllerian hormone, Gestational diabetes, Cohort, 030211 gastroenterology & hepatology, business, Live birth, Cell aging
Abstract

Background & Aims Premenopausal women who are HCV positive (HCV+) have failing ovarian function, which is likely to impact their fertility. Thus, we investigated the reproductive history, risk of infertility, and pregnancy outcomes in women of childbearing age who were HCV+. Methods Three different groups were studied: (1) Clinical cohort: 100 women who were HCV+ and also had chronic liver disease (CLD), age matched with 50 women who were HBV+ with CLD and with 100 healthy women; all women were consecutively observed in three gastroenterology units in hospitals in Italy; (2) 1,998 women who were HCV+ and enrolled in the Italian Platform for the Study of Viral Hepatitis Therapies (PITER); (3) 6,085 women, who were mono-infected with HCV, and 20,415 women, who were HCV−, from a large de-identified insurance database from the USA. Measurements: total fertility rate (TFR) defined as the average number of children that a woman would bear during her lifetime. To define the reproductive stage of each participant, levels of anti-Müllerian hormone (AMH) and 17β-estradiol were measured. Results Clinical cohort: women who were either HCV+ or HBV+ had similar CLD severity and age at first pregnancy. Based on a multivariate analysis, women who were HCV+ had a higher risk of miscarriage than those who were HBV+ (odds ratio [OR] 6,905; 95% CI 1.771–26.926). Among women who were HCV+, incidence of miscarriage was correlated with median AMH level (1.0 ng/ml). Achieving a sustained virologic response (SVR) after antiviral treatment reduced the risk of miscarriage (OR 0.255; 95% CI 0.090–0.723). In the PITER-HCV cohort, miscarriage occurred in 42.0% of women (44.6% had multiple miscarriages). TFR for women who were HCV+ and between 15 and 49 years of age was 0.7 vs. 1.37 of Italian population of the same age range. In the US cohort: compared with women who were HCV−, women who were HCV+ positive were significantly more likely to have infertility (OR 2.439; 95% CI 2.130–2.794), premature birth (OR 1.34; 95% CI 1.060–1.690), gestational diabetes (OR 1.24; 95% CI 1.020–1.510), and pre-eclampsia (OR 1.206; 95% CI 0.935–1.556), and were less likely to have a live birth (OR 0.754; 95% CI 0.622–0.913). Conclusions Ovarian senescence in women of childbearing age who are HCV+ is associated with a lower chance of live birth, greater risk of infertility, gestational diabetes, pre-eclampsia and miscarriage. Such risks could be positively influenced by successful HCV cure. Lay summary Most new cases of HCV infection are among people who inject drugs, many of whom are young women in their childbearing years. Women of reproductive age who are HCV+ display markers of ovarian senescence. This is associated with an increased burden in terms of infertility and adverse pregnancy outcomes, including stillbirth, miscarriage, fewer live births, and gestational diabetes. Early viral suppression with therapy is likely to mitigate these risks.

Published
2017

50. Corrigendum to 'Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV' [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou, A., Han, X., Kondili, L. A., Taliani, G., Ciancio, A., Morisco, F., Critelli, R. M., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A. S., Bruno, S., Bao, Y., Gonzalez, Y. S., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou A., Han X., Kondili L.A., Taliani G., Ciancio A., Morisco F., Critelli R.M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A.S., Bruno S., Bao Y., Gonzalez Y.S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M.C., Bigliotti E., Tamburrini F., Montalto G., Capitano A.R., Ieluzzi D., Fattovich G., Zignego A.L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F.P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D.C., Andreone P., Simonetti G., Gaeta G.B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L.E., Quaranta M.G., Falzano L., and Mallano A.

Subjects
Hepatology, Hepatitis B, EASL guidelines, Treatment, Interferon, Entecavir, Tenofovir, TAF, HBsAg, Hepatocellular carcinoma, HBV DNA, HBV reactivation, Mother to child transmission, EASL guideline
Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

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